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Utilizing knowledge and understanding of cGMP (Current Good Manufacturing Practices), ISO standards, and the company's Quality Management System, the Facilities Engineer will oversee the coordination, compliance, and documentation requirements for all facilities projects.
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A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site. As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert.
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Comply with all current Good Manufacturing Practices (cGMP) requirements to ensure products are consistently produced and controlled according to the Quality Management System (QMS). You will assemble a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met under the direction of the Production Team Leader/Supervisors.
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Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories. The Director of QCTS is responsible for the supervision of QCTS personnel, and the optimization of department resource allocation according to project/program needs to assure activities occur in an efficient, timely and cGMP compliant manner.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Who will be providing scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Experience with DeltaV Process Control System and SAP in a cGMP environment is desirable. Actively leads a bulk chemical manufacturing production line working with other shift supervisors to ensure consistency across all shiftsDevelops weekly production schedule by partnering with Production Planning, Supply Chain, Quality, and Product Management teams.
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Compliance with CGMP standards for consistent product quality. This entails working across one or more production lines under the direction of Production Team Leaders and Supervisors, ensuring adherence to standard documentation, maintaining quality standards, and meeting production rates.
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Have an expert level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans. Maintain the site’s Quality Systems’ conformance to ISO standards and regulatory requirements and policies.
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Quality Engineer III (Medical Device & Manufacturing) Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release. A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
$35 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Skills:Inspection, GMP, Clean Room, Packaging, Quality Assurance Experience:Entry Level1 year(s) responsibilities: Responsible for the labeling and packaging of pharmaceuticals for world wide distribution.
$23.5 - $24 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Complies with company, quality and safety standards, policies and procedures. Operates a variety of wafer fab equipment in a clean room production environment. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.
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2+ years of experienceThorough understanding of maintenance, reliability, Mechanical Integrity and Quality Assurance, and Process Safety Management best practicesExperience working in an ISO Certified, FDA Regulated, or cGMP environmentIndustry experience with machine set-up fundamentals and solid troubleshooting skills.
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Good data analysis skills, with an ability to use statistical methods to conduct quality investigations. Write or revise standard quality control operating procedure and quality system documentation as required.
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And continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.
$160,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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5 years of QA experience in cGMP and FDA inspection. Author, review, and approve SOPs and cGMP documents. Maintain compliance with Quality Assurance systems. Support production team and quality unit.
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cgmp quality jobs in Lowell, MA
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